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Pain Relief Roll-on

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
May 24, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
May 24, 2018
Manufacturer
Rite Aid
Registration number
part348
NDC root
11822-1116
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

This medication is designed to provide temporary relief from pain and itching. It can be helpful in managing discomfort associated with various conditions, allowing you to feel more comfortable in your daily activities. If you're experiencing pain or itching, this drug may be a suitable option to consider for short-term relief.

Uses

You can use this medication for the temporary relief of pain and itching. It’s designed to help ease discomfort, making it a useful option when you need quick relief from these symptoms.

Rest assured, there are no teratogenic effects (which means it doesn’t cause birth defects) or nonteratogenic effects (which refers to other types of harmful effects) associated with this medication. This makes it a safer choice for those concerned about potential risks.

Dosage and Administration

You can use this medication to help with your skin condition by applying it directly to the affected area. For adults and children aged 2 years and older, you should apply it no more than 3 to 4 times a day. If your child is under 2 years old, it’s important to consult a doctor before using this medication.

Make sure to follow these guidelines closely to ensure the best results. Remember, applying the medication too frequently may not provide additional benefits and could lead to irritation. Always wash your hands before and after applying the medication to keep the area clean and avoid spreading any infection.

What to Avoid

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you or someone else swallows it, seek medical help or contact a Poison Control Center right away.

There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always use it responsibly and follow any additional guidance from your healthcare provider.

Side Effects

When using this product, it's important to follow the directions carefully. It is meant for external use only, so avoid contact with your eyes and do not apply it in large amounts, especially on raw or blistered skin. If your condition worsens, or if symptoms last more than 7 days or return after clearing up, you should stop using the product and consult a doctor.

By being mindful of these guidelines, you can help ensure a safer experience while using the product.

Warnings and Precautions

This product is for external use only, so please use it as directed. Be careful to avoid contact with your eyes, and do not apply it in large amounts, especially on raw or blistered skin. If your condition worsens, or if your symptoms last longer than 7 days or come back after improving, stop using the product and consult your doctor.

If you accidentally swallow this product, seek emergency medical help or contact a Poison Control Center right away. Your safety is important, so please follow these guidelines closely.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to err on the side of caution when it comes to your health. Remember, if you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

It is important to be cautious if you are pregnant or planning to become pregnant. The safety of this product during pregnancy has not been established, and it is generally not recommended for use in pregnant women due to potential risks to the fetus. These risks may include adverse effects that could impact fetal development.

If you are considering using this product while pregnant, it is crucial to consult your healthcare provider for personalized advice and possible dosage modifications. Your healthcare provider can help you weigh the benefits and risks to ensure the best outcome for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

When using this medication for children, you can apply it to the affected area no more than 3 to 4 times a day for kids aged 2 years and older. However, if your child is under 2 years old, it's important to consult a doctor before use.

Always keep the medication out of reach of children. If your child accidentally swallows it, seek medical help or contact a Poison Control Center right away. Your child's safety is the top priority, so following these guidelines is essential.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you or how your liver health should be considered when taking it.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your liver health. They can help determine the best approach based on your individual circumstances.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This way, you can work together to ensure your treatment is safe and effective.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F), but try to keep it within the recommended limits. Make sure to protect the product from light and always keep the container tightly closed when not in use.

Once you open the container, remember to discard any remaining product, as it should not be reused. Following these guidelines will help maintain the safety and effectiveness of your product.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If the patient is under 2 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is the primary use of this drug?

This drug is used for temporary relief of pain and itching.

How should I apply this drug?

For adults and children 2 years of age and older, apply to the affected area not more than 3 to 4 times daily. For children under 2 years, consult a doctor.

Are there any contraindications for this drug?

There are no specific contraindications listed, but it is not recommended for use in pregnant women due to potential risks.

What should I do if I accidentally swallow this drug?

If swallowed, get medical help or contact a Poison Control Center immediately.

What precautions should I take when using this drug?

Use only as directed, avoid contact with eyes, and do not use in large quantities, especially over raw surfaces or blistered areas.

What should I do if my condition worsens or symptoms persist?

Stop use and ask a doctor if your condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Is this drug safe to use during pregnancy?

Safety during pregnancy has not been established, and there may be risks to the fetus associated with its use.

What are the storage conditions for this drug?

Store at 20°C to 25°C (68°F to 77°F), protect from light, and keep the container tightly closed.

Packaging Info

Below are the non-prescription pack sizes of Pain Relief Roll-on (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pain Relief Roll-on.
Details

Drug Information (PDF)

This file contains official product information for Pain Relief Roll-on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No specific description details related to SPL code 34089-3 are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, the recommended dosage is to apply the medication to the affected area no more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a healthcare professional prior to use to determine the appropriate course of action.

Contraindications

Use of this product is contraindicated in the following situations:

  • The product should be kept out of reach of children to prevent accidental ingestion.

  • In the event of accidental swallowing, immediate medical assistance or contact with a Poison Control Center is required.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. Healthcare professionals should advise patients to avoid contact with the eyes and to refrain from applying the product in large quantities, especially on raw surfaces or blistered areas.

Patients are instructed to discontinue use and consult a physician if their condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, medical advice should be sought.

In the event of accidental ingestion, immediate medical assistance should be obtained, or the patient should contact a Poison Control Center without delay.

It is imperative that healthcare providers monitor patients for any adverse reactions and ensure that they are aware of the importance of adhering to these warnings and precautions for safe use.

Side Effects

Patients should be aware that this product is for external use only. It is essential to use the product strictly as directed to minimize the risk of adverse reactions. Care should be taken to avoid contact with the eyes, and the product should not be applied in large quantities, especially over raw surfaces or blistered areas.

In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to stop use and consult a doctor. These precautions are critical to ensure the safe and effective use of the product.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Pain Relief Roll-on (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pain Relief Roll-on.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use.

It is important to keep the medication out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Safety during pregnancy has not been established for this product. It is not recommended for use in pregnant women due to potential risks to the fetus. There may be risks associated with the use of this product during pregnancy, and healthcare providers should be consulted for advice on dosage modifications and overall management. Women of childbearing potential should be informed of these risks and the importance of discussing any potential use during pregnancy with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management strategies tailored to the substance involved.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of seeking immediate medical assistance or contacting a Poison Control Center if the medication is swallowed. This information is vital for ensuring patient safety and preventing potential harm.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to ensure its stability. Once opened, the product should be discarded to prevent any potential degradation or contamination.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, clinicians are advised to consult a doctor prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Pain Relief Roll-on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Pain Relief Roll-on, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.